Filled capsules

ABSTRACT

A method for making filled capsules containing dry material in which the dry material is placed into a capsule body to a level slightly below the open end of the body and a measured amount of molten gelatin is placed over the body&#39;&#39;s open end in contact with the dry material whereby upon solidification of the molten gelatin a fused joint is effected with the capsule body&#39;&#39;s open end.

United 9 States Patent Allisbaugh 1 Apr. 4, 1972 [54] FILLED CAPSULES [7 21 Inventor: Howard C. Allisbaugh, Indianapolis, Ind. [73] Assignee: Eli Lilly and Company, Indianapolis, lnd.

[22] Filed: July 11, 1969 [21] Appl. No.: 841,044

[52] U.S.Cl ..206/56 AA,53/24, 99/181,

206/84, 424/37 [51] Int. Cl B65d 79/00, A6lk 9/04, B6Sb l/OO [58] Field of Search ..53/24, 25, 124, 124 B, 37,

53/39, 140, 32-34, 2 PC, 111 RC; 424/37; 99/181; 206/84, 56 AA [56] References Cited UNITED STATES PATENTS 2,329,928 9/1943 Mulligan ..53/21 FC 464,121 12/1891 Heineman.. ..424/21 1,256,307 2/1918 Grant ..99/181 1,792,010 2/1931 Goss 424/37 X 1,846,052 2/1932 Grant ..99/181 1,911,020 5/1933 Grant ..99/181 2,046,609 7/1936 Clark ..99/181 2,028,241 1/1936 Paul ..53/24 2,031,660 2/1936 Loepslnger 53/25 2,046,366 7/1936 Collins ..53/24 2,046,367 7/1936 Collins... ..53/24 2,379,342 6/1945 Cozzoli ..53/25 3,078,629 2/1 963 Besemer ..53/37 3,162,000 12/1964 Kraven 3,324,902 6/1967 Lense 3,505,775 4/1970 Andersen..

3,518,340 6/1970 Raper ..53/37 X Primary Examiner-'Wayne A. Morse, Jr. Altorney-Everet F. Smith and Houston L. Swenson [57] ABSTRACT A method for making filled capsules containing dry material in which the dry material is placed into a capsule body to a level slightly below the open end of the body and a measured amount of molten gelatin is placed over the body's open end in contact with the dry material whereby upon solidification of the molten gelatin a fused joint is effected with the capsule bodys open end.

1 Claims, 4 Drawing Figures Patented April 4, 1972 m m T N LE 0 M M 2 INVENTOR. HOWARD C. ALLISBAUGH ATTO RNEY FILLED CAPSULES BACKGROUND OF THE INVENTION Filling pre-formed empty hard-gelatin capsule bodies with medicinal or other dry powders, then closing with a preformed capsule cap, is the current method of dispensing many dry medicines. This method of closing hard-gelatin capsules is universally acceptable in all pharmaceutical houses but has certain disadvantages. Many hard-gelatin capsules contain very expensive formulations, and some even contain small compressed tablets of a second medicament designed to supplement the action of powders in the capsules. Unauthorized persons may, and frequently do, remove the cap from the capsule, dilute the powder component with a suitable filler, then refill the capsule with the diluted original contents. The expensive; tablet in some capsules may also be removed. The usual method of detection of this unauthorized modification of the formula is failure to obtain expected therapeutic response on admimistration of the medication.

An even more common problem is the accidental separation of one or several capsule caps from their filled bodies while being handled and shipped. Powder from the separated bodies will sift among other capsules in the bottle causing them to take on an unappealing dusty appearance. If the powder is bitter, then it may be necessary to discardthe entire contents of the bottle.

Certain manufacturers eliminate the above problems by sealing the body to the cap by applying a band of hot gelatin solution over the junction of the edge of the cap and the side of the body of the filled capsules. Locking type capsules have also been developed with recessed and raised surfaces in the capsule caps and bodies which cooperate to minimizeaccidental separation.

SUMMARY OF THE INVENTION I have found that accidental spillage, tampering with and pilfering of medication from filled capsules can be prevented by closing the hard-gelatin capsule bodies by the following method. The hard-gelatin capsule body is filled with the desireddry powder to a level slightly below the capsule bodys open end. In some instances it may be desireable to then tamp or vibrate the filled capsule body to obtain a certain degree of compacting. After the body has received the powder a measured amount of molten gelatin is placed over the open end of the capsule and in contact with the exposed surface of the dry powder. The measured amount is such that a neat-appearing curved surface is fused with the bodys open end upon coupling and solidification of the molten gelatin. As drying of the fused capsule wall and the molten gelatin progresses, the fused and softened capsule body wall shrinks tightly to the gelatin closure thereby forming a one-piece capsule which is impossible to open without destruction.

BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a perspective view of a filled capsule sealed in accordance with my invention.

7 FIG. 2 is a longitudinal section of the capsule of FIG. 1.

FIG. 3 is a longitudinal section of a capsule body filled with dry powder prior to sealing the body.

FIG. 4 is a schematic view of the method of this invention for sealing filled capsule bodies.

DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIGS. 1 and 2, a filled and sealed capsule 11 is shown containing a dry powder 13. Capsule 11 is a conventional capsule body 15 which has been formed from gelatin. In the pharmaceutical industry these partially brittle capsules are known as hard-gelatin capsules. A closure 17, also formed from gelatin is shown fused with the open end 18 of body 15. It is to be noted that the open end 18 is slightly curved inwardly due to a shrinkage process to be subsequently explained.

In making capsules of the above type, capsule body 15 is first filled with dry powder 13. It is desirable that the top level 20 of the dry powder is slightly below the body's open end 18. Thus, if a particular quantity of powder to be placed in the body is such that tamping or vibration is called for, the capsule may first be completely filled. However, prior to sealing the capsule it is desirable to lower thelevel of the dry powder to approximately one-sixteenth of an inch below a size 0 capsule in order to obtain a well-fused closure on the body.

As shown in FIG. 4, capsule bodies 15 with their open ends upward are positioned in a conveyor means 21. Upon filling the bodies with dry powder the conveyor means may travel across a vibratory table or under a reciprocating tamping pad 23 to obtain a slight lowering of the powder beneath the open ends of the capsule bodies. Pad 23 has a resilient surface 26 which, when pressed onto open ends 18 of the capsules, slightly depresses the powder level 20. The capsule bodies are then conveyed to a sealing station which in the schematic drawing of FIG. 4 introduces a measured amount of molten gelatin 22 onto each bodys open end. The preferred amount of molten gelatin to be dropped onto the open end of a size 0 capsule body is approximately 0.22 ml. The temperature of the molten gelatin is preferably between l30l60 F.

A valve means 24 is provided in communication through conduit 25 with a reservoir of molten gelatin 27. Valve means 24 may comprise a structure similar to a hypodermic syringe which is activated in synchronization with the advance of the unsealed capsules to automatically drop a predetermined amount of molten gelatin.

The filled, and now sealed, capsule bodies are left in their conveyor until closure 17 has completely solidified and dried sufficiently to avoid sticking with other filled and sealed capsules. As the drying of closure 17 occurs, the now softened body end 18 fuses and shrinks tightly to the closure, thereby forming a unitary capsule that cannot be separated without destroying it. The capsule body end 18 is drawn inwardly and the inner surface of closure 17 is drawn upwardly due to the shrinkage processes during the solidifying of the molten gelatin.

The advantages of producing capsules of this method are numerous and include substantial savings in cost and time with respect to material and production methods. Since only a capsule body is used with a small amount of additional gelatin for closure 17, it is apparent that nearly twice as many capsules can be made with the same amount of gelatin normally required for forming two-piece capsules. In the prior art the filling and assembling of two-piece capsules has required apparatus that must be maintained without any wear on the parts. In particular, the problems normally encountered in assuring that the joining process of telescoping a cap over a body does not split a cap or body section are eliminated. Current production of two-piece capsules has required discarding an entire capsule when a flaw is detected in either the cap or body. The capsule of this invention, if defective, calls for only the discarding of the body and the small closure 17. The wall thickness of a capsule body for my novel capsule is not a critical dimension since it is no longer necessary to telescope a cap section over it.

The filling operation for producing capsules in accordance with my invention is substantially speeded up over that currently in use for two-piece capsules; Since may method uses only a body it is no longer necessary to separate a cap section from a body section prior to filling the body section. A bank of automatic syringes may be used to deliver the measured amounts of molten gelatin onto the open ends of the filled bodies. Thus, relatively simple equipment may be used to seal at least capsule bodies per minute in a single row. In a large production operation a number of rows of capsule bodies can be simultaneously filled thereby producing several hundred sealed capsules per minute. The drying cycle of these sealed capsules may be accelerated by providing a flow of controlled dehumidified air at a predetermined temperature.

This method has been found applicable for all sizes of capsules. Upon determining the amount of shrinkage occurring for a particular size capsule body, a predetermined amount of molten gelatin may be dispensed by the syringes to produce a smooth contoured end that is esthetically appealing to the trade. Closure 17 may be of a different colored gelatin to provide a two-color combination capsule. Where two-piece capsulcs have generally called for printing of a companys logo on each capsule section, it is apparent that this printing operation may be halved by merely printing on the capsule body 

